The Recall Desk

Manufacturer

AMS Innovative Center - San Jose

1 recall in our database name AMS Innovative Center - San Jose as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2013-01-30

Of the 1 recalls from AMS Innovative Center - San Jose we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • ModerateFDA (Devices)·Z-0700-2013·2013-01-30

    AMS GreenLight HPS and XPS Surgical Lasers Recalled for Electrical Non-Conformance

    AMS Innovative Center is recalling 389 GreenLight HPS and XPS surgical laser systems because the Voltage Scaling Board failed to meet IEC 60601-1-2 electrical safety standards.

    Product
    GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of t
    Category
    Medical Device
    Distribution
    0 states